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Provenge just got FDA approval. Finally.

Huge news for Seattle based Dendreon (NASDAQ: DNDN) - the US Food and Drug Administration has finally approved Provenge (Sipuleucel-T) for use in treating metastisized prostate cancer as of April 29th. Provenge, which uses the body's own immune system to hunt down and destroy cancer cells, is the first treatment of its kind to win FDA approval. The decision comes almost exactly one year after encouraging evidence from Phase III clinical trials showed that the therapy would extend life an average 4.1 months over placebo. Dendreon stock rose a hefty ~26% ($10.50) the day of the FDA approval announcement. With this burgeoning success, Dendreon and Provenge may be leading the way for other autologous immunotherapies to help revolutionize healthcare.

It was only a few weeks ago that we reviewed Dendreon's steady journey towards FDA approval over the past year. From that discussion you'll remember that the Provenge therapy gives a patient's own immune cells (T-cells) the proteins necessary to seek out antigens that appear on prostate cancer cell membranes. This T-cell training, called Active Cellular Immunotherapy (ACI), lets your body fight prostate cancer that has already spread through out the body (castrate resistant prostate cancer (CRPC)). The ACI process of granting cells new proteins to "train" them for a specialized task is likely to be ported over to new applications. With the right protein/antigen relations your body could possibly be made to hunt many different cancers as well as other dangerous cells. It will be interesting to see how ACI technology is adapted in the years ahead.

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Dendreon stocks rose 26% with Provenge's FDA approval. That's a sweet victory after prices plummeted more than three years ago over concerns it wouldn't get cleared for use.

For now, all eyes are on Dendreon and their move from clinical trials to rolling out Provenge to market. In their webcast news conference, Dendreon explained how it would proceed in the next twelve months. They had already begun developing three manufacturing plants for Provenge before FDA approval (as early as 2006). In the next year, Dendreon will complete construction and secure licensure for these plants. With the facilities they already have the company is looking to provide full treatments for about 2000 patients in the months ahead. Those patients will be treated in about 50 oncology clinics around the US and Canada, all (or most) of which were involved in Provenge/Sipuleucel-T clinical trials. A Dendreon spokesmen said that Provenge will be priced around $31,000 per infusion, with three infusions necessary for a full treatment ($93k total). They anticipate that most insurances will cover the treatment, and they've set up a patient access program (read: financial assistance). Provenge.com has been updated, and a "Dendreon On-Call" service will be available to provide oncology support for patients as well as guide them in accessing the treatment.

While 2000 patients in the first twelve months is a respectable number, Dendreon expects it will fall short of the expected demand for the new therapy. Why is Provenge likely to be so popular? Taxotere, the only real chemotherapy solution for men with CRPC only extends average lifespan by about 3 months, and it has all the standard side effects associated with chemotherapy: nausea, hair loss, extreme fatigue, etc. Provenge has an average extension of 4 months, has much milder flu-like side effects, and patients typically receive all three infusions (the full treatment) in about a month's time. In the webcast Dendreon stated that it's per month of expected extended life costs were around $23,000. Which they claim compares very favorably to any other treatment option.

Clearly Provenge is just starting on the path to really proving itself in the oncology treatment market. All signs point to it being very successful, (will it reach $1 billion in sales by 2016 as suggested by analysts referenced by the AP?) but it's too soon to know exactly how it will fair in the months ahead. Taking a longer look, ACI has some serious potential for augmenting the way we treat cancer and other illnesses. With this technique, your body's immune system may be the first form of nanotechnology that you ever use. Those possibilities are years ahead of us. For now, the US has 192,000 new cases of prostate cancer every year, and 27,000 deaths from the illness. Provenge represents new hope for these men, and those all over the world, facing those numbers.

[image credit: Provenge, Yahoo Finance]
[source: Associated Press, Dendreon Webcast, Dendreon Press Release, Provenge, American Cancer Society, Yahoo Finance]